[PDF] Table of Contents Foreword by Congresswoman Porter 2



Previous PDF Next PDF









(6*/26( ( &26726 )69 - Gob

õ ï î )ljxud *uiilfd flufxodu gho srufhqwdmh gh frvwrv gh surgxfflyq gh xqd hpedufdflyq )69 wrpdqgr frpr uhihuhqfld od 7deod '(6*/26( '( &26726



Table of Contents Foreword by Congresswoman Porter 2

2 Foreword by Congresswoman Katie Porter I hear it all the time from Orange County families: the cost of prescriptions is too high This rings true across the country: Nearly 1 in 5 Americans reported skipping a dose because of



Cuadernos de Innovaci n en la Docencia Universitaria

8 Cuadernos de Innovaci n en la Docencia Universitaria 2019 PontiÞcia Universidad Cat lica del Per 9 `Z[VY`[LSSPUN WYV`LJJP}UPUTLYZP]H `LS\ZVKLOLYYHTPLU[HZ[LJUVS}NPJHZ LKW\aaSL ZVJYH[P]L ,TWYLUKLJSHZZ 4 VVKSLJ VUK PZLVP U[\P[P]V *VU[LUPKVZ`LZ[YH[LNPHZPUUV]HKVYHZLU\UJ\YZVPU[LYKPZJPWSPUHYPV ;YLZL_WLYPLUJPHZWYVWVULU



Fast Fashion: Business Model Overview and Research Opportunities

Competitividad, formerly Ministerio de Ciencia e Innovaci¶on) - ref ECO2011-29536 1 emergence of new industry players { collectively known as \fast-fashion retailers" { which



An Evaluation of Crown Heights Save Our Streets, a

Executive Summary iii EXECUTIVE SUMMARY Save Our Streets (SOS) is a community-based project established to address the problem of gun violence in Crown Heights, a neighborhood in central Brooklyn, New York



Los sistemas RegionaLes de innovación en améRica Latina

Los sistemas RegionaLes de innovación en améRica Latina Juan José Llisterri y Carlo Pietrobelli con la colaboración de Mikael Larsson (Editores)

[PDF] Inch to Metric Conversion Chart - Bearing King

[PDF] Imches To Millimeters - WalzCraft

[PDF] équivalence pouce millimètre - Longjuflex

[PDF] Pourcentages - Académie en ligne

[PDF] Pourcentages : Résumé de cours et méthodes 1 - Xm1 Math

[PDF] Imches To Millimeters - WalzCraft

[PDF] Inches to mm Conversion - Engineering ToolBox

[PDF] 1 Quelques séries dont on sait calculer la somme 2 Comparaison

[PDF] Diplôme d 'Etat d 'infirmier Référentiel de compétences - Infirmierscom

[PDF] les conditions d 'apprentissage des adultes - cedip

[PDF] Télécharger la fiche (PDF) - Cercle Gallimard de l 'enseignement

[PDF] Orientation : les trois quarts des élèves de seconde générale et

[PDF] DECLARACION UNIVERSAL DE DERECHOS HUMANOS El 10 de

[PDF] Les 10 principaux Droits de l 'enfant

[PDF] The Healthy Kids Strategy - Ministry of Health and Long-Term Care

Table of Contents

Foreword by Congresswoman Porter 2

Consolidation in the Pharmaceutical Industry 3

Innovation is Disappearing 5

The Development of Enbrel 9

The Amgen-Immunex Acquisition 10

The Path Forward 13

2

Foreword by Congresswoman Katie Porter

I hear it all the time from Orange County families: the cost of prescriptions is too high. This rings true across the country: Nearly 1 in 5 Americans reported skipping a dose because of most profitable industry sector̝even if it lost $1 trillion in sales.2 Yet, moving drug pricing reform through Congress remains nearly impossible. Last year, the House of Representatives passed the Elijah E. Cummings Lower Drug Costs Now Act, but the Senate has failed to move this legislation forward. Pharmaceutical companies, and the Anyone who has ever purchased a car can tell you that negotiation is central to capitalism. So is price transparency, competition, and consumer choice. By any metric of a healthy market, the prescription drug industry fails. Pharmaceutical companies have little incentive to invest in innovative new medicine without the threat of competition. Instead, they are free to devote their considerable resources to merging with or acquiring companies that might otherwise force them to compete. This consolidation has destroyed scientific cultures that once celebrated creativity and transformed them into places that cater to the whims of shortsighted shareholders. Rather than producing breakthrough, lifesaving drugs for diseases with few or no cures, most companies focus on small, incremental changes to existing drugs in order to kill off generic threats to their government-granted monopoly patents. The rapid breakthroughs that we have seen in response to the COVID-19 pandemic highlight that innovation is possible. But without taxpayer funded research, we likely would not see these signs of hope. Companies with billions in profits have relied on our dollars to support where Big Pharma relies on the creativity of academic researchers and small biotechnology One episode of this story is the merger between Immunex, a small biotechnology firm, and on innovation that result from this kind of acquisition. But our investigation also shows us how we can chart a new path forward, increasing competition and saving lives.

Very Truly Yours,

Katie Porter

2 A Comparison of Returns Between Pharmaceutical & Other Industries, WHPC, Retrieved at: https://www.westhealth.org/wp-content

3 McConnell warns Pelosi's drug-pricing plan is DOA, POLITICO, Retrieved at: https://www.politico.com/story/2019/09/19/mcconnell-

pelosi-prescription-plan-1504496 3

Consolidation in the Pharmaceutical Industry

In just 10 years, the number of large, international pharmaceutical companies decreased six- fold, from 60 to only 10.4 The number of mergers and acquisitions (M&A) involving one of the top 25 firms in the pharmaceutical industry more than doubled from 2006 to 2016,5 and the Johnson & Johnson, Roche, Pfizer, Novartis, Merck, GlaxoSmithKline, Sanofi, Abbvie, Bristol Myers Squibb, AstraZeneca, Amgen, Gilead, and Teva.7 Pharmaceutical company CEOs attempt to frame these deals as simply efforts to improve a troubling industry-wide trend of billions of dollars of corporate resources going toward acquiring other pharmaceutical corporations with patent-protected blockbuster drugs like this: a small firm will develop a breakthrough drug, and then will be acquired by a slightly larger firm, which will later be acquired by one of the giants discussed before, or will be acquired outright by one of these megafirms.9,10 The reasons for the M&A deals are highly varied: some are done to boost stock prices, while others are done to stop competitors, and many are done to acquire an innovative blockbuster drug with an enormous prospective revenue stream.11,12 Instead of spending on innovation, Big Pharma is hoarding its money for salaries and dividends,13 all while swallowing smaller companies, thus making the marketplace far less competitive.14 This behavior has an overall negative effect on investments in

4 High Drug Prices and Monopoly, Open Markets Institute, Retrieved at: https://www.openmarketsinstitute.org/learn/drug-prices-

monopoly

5 Drug Industry: Profits, Research and Development Spending, and Merger and Acquisition Deals, Government Accountability Office,

Retrieved at: https://www.gao.gov/products/GAO-18-40

6 Pharmaceutical mergers and megamergers stifle innovation, STAT, Retrieved at:

7 The top 20 pharma companies by 2019 revenue, Fierce Pharma, Retrieved at: https://www.fiercepharma.com/special-report/top-20-

pharma-companies-by-2019-revenue

8 Ibid.

9 The Roles of Academia, Rare Disease, And Repurposing in the Development of the Most Transformative Drugs. Health Affairs,

Retrieved at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2014.1038

10 Consolidation and Innovation in the Pharmaceutical Industry: The Role of Mergers and

Acquisitions in the Current Innovation Ecosystem, Journal of Health Care Law and Policy, Retrieved at:

11 Pharmaceutical M&A: A New Kind of Drug Deal, Health Trust, Retrieved at: https://healthtrustpg.com/thesource/pharmacy-

13 Profit Over Patients: Americans are Paying for a Financialized Pharmaceutical Industry, Roosevelt Institute, Retrieved at:

industry/

14 Pharmaceutical mergers and megamergers stifle innovation, STAT, Retrieved at:

the number of large, international pharmaceutical companies decreased six- fold, from 60 to 4 reduced innovation industry wide.15 A Harvard Business Review study found that in mergers of

entity decline substantially after a merėāũ̧̈16 In other words, the less competition that exists

in the pharmaceutical industry, the less likely the industry will actually focus on innovation and new cures that can save lives.17 The Pharmaprojects database, which allows researchers to track the progress of drugs from early development through market launch, tells a similar story: One analysis of the database found that during this era of consolidation, from 2000 to 2008, nearly 2,000 drugs in discovery were discontinued and the vast majority of these decisions were made not because discontinuation.19 In recent years, some of the biggest mergers and acquisitions provide examples of this behavior: Bristol-Myers Squibb acquired Celgene in 2019.20 Celgene is well known for its cancer drug, Revlimid, which has garnered attention in recent years for aggressive and unexplained price hikes.21 Celgene had recently acquired Juno, an innovative young biotechnology firm from pipeline of CAR-T blood cancer drugs.22 In 2019, AbbVie, the producer of Humira, acquired Allergan, the producer of botox.23 Humira is a blockbuster drug, which brings in billions a year for AbbVie.24 The company has abused the patent system to delay a generic option from coming to market.25 Just as these patents started to run out, and there were few choices left to defend their profits, the company acquired Allergan in order to increase its funding streams. Together AbbVie and Bristol-Myers Squibb are responsible for nearly 10% of all M&A deals over the last decade.26 Five of the six largest acquisitions in the study took place from 2017-

15 "How mergers affect innovation: Theory and evidence from the pharmaceutical industry," DICE Discussion Papers 218, University of

16 Research: Innovation Suffers When Drug Companies Merge, Harvard Business Review, Retrieved at:

17 Drug Mergers Hurt in Every Direction (Save One), Science Mag, Retrieved at:

18 Vertical disintegration: a strategy for pharmaceutical businesses in 2009?, Nat Rev Drug Discov, Retrieved at:

19 Conversation with Laurent Galibert, October 16, 2020.

20 Pharmaceutical mergers and megamergers stifle innovation, STAT, Retrieved at:

21 Celgene repeatedly raised Revlimid's price to hit aggressive sales targets, congressional probe finds, Fierce Pharma, Retrieved at:

and Celgene Buys Juno Therapeutics: A Risky $9B Bet, Forbes, Retrieved at:

23 Pharmaceutical mergers and megamergers stifle innovation, STAT, Retrieved at:

24 AbbVie Reports Full-Year and Fourth-Quarter 2018 Financial Results, AbbVie, Retrieved at: https://news.abbvie.com/news/abbvie-

25 ̪, US PIRG, Retrieved at:

26 A Decade of Biopharma M&A and Outlook for 2020, Pharma Intelligence, Retrieved at:

5

2019,27 likely propelled forward by the passage of tax reform in 2017.28 An analysis from

consulting firm McKinsey found that, in the first half of 2018, there were 212 deals in the pharmaceutical sector, up from 151 deals in the same period the year prior.29

Innovation is Disappearing

anticompetitive, profit-driven behaviors. Pharmaceutical companies often claim that lowering the prices of prescription drugs in the United States would devastate innovation.30 Yet, more and more of their funds to enrich shareholders or to purchase other companies to eliminate competition.32 wealthy went into effect, 12 of the biggest pharmaceutical companies spent more money on stock buybacks than on though the tax law exacerbated the issue. From 2008-

2018, big pharmaceutical companies spent more on stock

buybacks and dividends than they did on research and development.34 As their focus has shifted to shareholders and stock prices, innovative drug development has fallen. According to research from Harvard Medical School, the development of innovative and have groundbreaking effects on patient ũā̧ũāĢĿĢłĢŭĞĢłė̍35 Of 26 transformative drugs and drug classes approved between 1984 and 2009, only four were approved after 2000. The discovery of new molecular entities or novel drugs in the last decade (2000-2010) were in line with or slightly above those rates observed in the 1980s, despite technological improvements that should have catapulted new cures forward.36 Many of the drugs studied were based on substantial research and

27 Ibid.

29 Ibid.

30 Pharma Companies Argue That Lower Drug Prices Would Mean Fewer Breakthrough Drugs. Is That True?, Kellogg Insight, Kellogg

School of Management, Retrieved at: https://insight.kellogg.northwestern.edu/article/pharma-companies-argue-lower-drug-prices-

fewer-breakthrough-drugs

31 R&D Costs for Pharmaceutical Companies Do Not Explain Elevated US Drug Prices, Health Affairs, Retrieved at:

32 Financialization of the U.S. Pharmaceutical Industry, Institute for New Economic Thinking, Retrieved at:

33 Pharmaceutical companies spending on R&D and buybacks, Axios, Retrieved at: https://www.axios.com/big-pharma-stock-

35 The Roles of Academica, Rare Disease, And Repurposing In the Development of the Most Transformative Drugs. Health Affairs,

Retrieved at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2014.1038

36 Ibid.

that Donald giveaway to the wealthy went into effect, 12 of the biggest pharmaceutical companies spent more money on stock buybacks than on research 6 development work conducted by scientists at academic medical centers, supported by taxpayer dollars. At the same time, the number of infection outbreaks and unique diseases rose.37 In a functioning market, supply and demand would be more closely aligned. As new diseases requiring new cures emerged, new drugs should have increased at a similar pace. In reality, Instead of taking risks to find new, critically needed drugs, large pharmaceutical companies are just repackaging the same products over and over: In 2018, only 1 in 3 new brand-name in fact small changes for existing products that were created to extend patent monopolies.41 In fact, between 2005 and 2015, approximately 75% of new drug patents were for those already being sold on the market.42 Of the roughly 100 highest selling drugs, nearly 80% sought and received an additional patent to extend their monopoly period at least once; nearly 50% extended it more than once.43 Some of this may be an unintended consequence of the Orphan Drug Act, which provided financial incentives and innovative biologics or drugs that will treat a rare condition or disease (less than 200,000 people).44 Since the legislation was signed into law in 1983, more than 200 companies have Unfortunately, many drug companies have found ways to abuse this law, manipulating it to create monopolies on drugs that serve a larger swath of the population and charging astronomical prices.46 A Kaiser Health News study approved by the Food and Drug Administration for mass for more than one rare disease, and in some cases, multiple rare diseases. For each additional approval, the drugmaker

37 Infection outbreaks, unique diseases rising since 1980, Brown University, Retrieved at:

all-be-in-a-lot-of-trouble

39 Big pharma failing to invest in new antibiotics, says WHO, The Guardian, Retrieved at:

40 Center for Drug Evaluation and Research: ADVANCING HEALTH THROUGH INNOVATION 2018 NEW DRUG THERAPY APPROVALS,

United States Food and Drug Administration, Retrieved at: https://www.fda.gov/media/120357/download

41 Ibid.

42 May your drug price be evergreen, Journal of Law and the Biosciences, Retrieved at:

43 Ibid.

44 What is the Purpose of the Orphan Drug Act?, PLOS Medicine, Retrieved at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5207521/

45 Drugmakers Manipulate Orphan Drug Rules to Create Prized Monopolies, Retrieved at: https://khn.org/news/drugmakers-

46 Drugs For Rare Diseases Have Become Uncommonly Rich Monopolies, NPR, Retrieved at: https://www.npr.org/sections/health-

47 Drugmakers Manipulate Orphan Drug Rules to Create Prized Monopolies, Retrieved at: https://khn.org/news/drugmakers-

market, supply and demand would be more closely aligned. As new diseases requiring new cures emerged, new drugs should have increased at a 7 identify small patient populations to gain additional approvals, thus reaping financial incentives and securing market exclusivity for a longer period of time.48 Instead of focusing on the next big innovation in the industry, channeling their efforts into research, they concentrate on gaming the system. Recently, Gilead Sciences, the makers of remdesivir, an antiviral drug that has been considered as a possible COVID-19 treatment, submitted an application for approval of remdesivir as an orphan drug for COVID-19.49 Gilead sought this application in early March, when there were clear even in the earlier days of the pandemic, that there would ultimately be far more than

200,000 cases of COVID-19.

As the focus of Big Pharma has shifted away from competing with other companies and towards Wall Street, innovation has dropped off. In reality, most basic research is funded by or conducted through the National Institutes of Health,52 other government sources, and venture capitalists.53 This drives innovation in small labs firms, which are often spun off of taxpayer-funded academic research.54 These small labs are then purchased by giant firms after drug, as exhibited in the Celgene-Juno acquisition, and as will be discussed later with Amgen-Immunex. Research from McKinsey found that the share of revenues rose from 25 percent in 2001 to 50 percent in 2016.55 For example, Forest Laboratories, which has since been acquired by AbbVie, acquired Clinical Data in 2011, two weeks after it had received approval from the Food and Drug Administration for a novel antidepressant, Viibryd.56 Roche, another pharmaceutical giant, acquired Promedior, a research focused company, who had conducted research needed for the development of a drug for idiopathic promisȩ̍58

48 Ibid.

49 Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation, Gilead, Retrieved at:

50 Ibid.

52 Contributions of NIH funding to new drug approvals 2010-2016, Proceedings of the National Academy of Sciences, Retrieved at:

53 The Roles of Academia, Rare Disease, And Repurposing In the Development of the Most Transformative Drugs. Health Affairs,

Retrieved at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2014.1038

54 Pharma 101, Public Citizen, Retrieved at: https://www.citizen.org/article/pharma-101-a-primer/

56 A Decade of Biopharma M&A and Outlook for 2020, Pharma Intelligence, Retrieved at:

57 Ibid.

58 Ibid.

revenues coming from innovations from 25 percent in

2001 to 50 percent

8 (Source: McKinsey & Company, Evaluate Pharma, Pharma Projects Database)59 Big pharmaceutical companies are not responsible for most major breakthroughs in new drugs. The previously mentioned Harvard Medical School analysis found that the most centers in the discovery of transformative drugs are academic medical centers investing in and conducting the clinical trials necessary to gain FDA approval. However, the fraction of spent on the basic research that often generates truly innovative new compounds is estimated Many of the companies who take this initial stage research and guide it through further research and clinical trials are small biotechnology firms who cultivate creativity and foster innovative thinking. In 2018, small firms discovered

64% of drugs launched, up from 31% in 2009.62

Unfortunately for American patients, as soon as these companies are acquired, the innovation stops. The culture of creativity is killed. New pipeline drugs, as mentioned, are happens across the industry, and the story of Amgen and Immunex provides a perfect study.

60 The Roles of Academia, Rare Disease, And Repurposing In the Development of the Most Transformative Drugs. Health Affairs,

Retrieved at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2014.1038

61 Ibid.

62 Small Pharma Driving Big Pharma Innovation, PharmaVOICE, Retrieved at: https://www.pharmavoice.com/article/2020-01-

pharma-innovation/ firms discovered

64% of drugs

launched, up from 9 The Development of Enbrel In 2002, Amgen, one of these pharmaceutical giants, acquired Immunex, a small biotech firm focused on therapies for immune diseases.63 In exclusive conversations with former Immunex, and later Amgen, employees, my staff found that they all painted a similar picture: after the acquisition, the innovative, creative culture the company had worked so diligently to foster was destroyed. Piece by piece, it was broken down, until, as Amgen, at the time the largest biotech company in the world, announced that it would acquire Immunex in December 2001. The acquisition was completed in July 2002. Amgen initiated the acquisition because of a potential breakthrough drug that Immunex controlled: etanercept (Enbrel), which treats rheumatoid arthritis and other chronic immune-mediated diseases.64 These disorders result from the body mistakenly attacking its own cells. Enbrel helps block this by interfering with, or inhibiting, tumor necrosis factor (TNF), a signaling cell involved in the inflammation rheumatoid arthritis causes.65 In 1992, Marc Feldmann and Ravinder Maini demonstrated that TNF inhibiting therapy had tremendous potential to combat autoimmune disease like rheumatoid arthritis.66 This breakthrough science, which initially endured some skepticism,67 drew the attention of biotech companies: Roche and Genentech began research (first separately, then together after a merger) into one form of TNF receptor,68 while Immunex began research into another.69 Roche/Genentech began clinical trials in the US for rheumatoid arthritis, working with the lab were six months ahead of Immunex in their US clinical trials and had positive results in Europe, but the US trials were ultimately unsuccessful.71 At first, Immunex had previously experimented with anti-TNF treatments for patients with bacterial sepsis72 but this indication, or use, for the drug ultimately failed, destabilizing the from developing a sepsis therapy to studying the effects in rheumatoid arthritis.74 Immunex

63 Amgen Completes Acquisition Of IMMUNEX, Amgen, Retrieved at: https://investors.amgen.com/news-releases/news-release-

information/etanercept-enbrel/

65 Ibid.

66 Anti-TNF Therapy, from Rationale to Standard of Care: What Lessons Has It Taught Us?, Journal of Immunology, Retrieved at:

67 A Conversation with Marc Feldmann, Journal of Clinical Investigation, Retrieved at: https://www.jci.org/articles/view/71860

68 Roche and Genentech cloned and sought to bring to market the p55 soluble TNF receptor (lenercept).

69 Immunex focused on developing the p75 TNF receptor (etanercept).

70 Our office spoke with Dr. Michael Weinblatt who confirmed the details of his work on the development of Enbrel and of the other

details provided here about the discovery process.

71 Treatments no longer in development for rheumatoid arthritis, BMJ Journals Retrieved at:

https://ard.bmj.com/content/61/suppl_2/ii43#ref-27 and An Assessment of the Effect of Anti-Drug Antibody Formation on the

Pharmacokinetics and Pharmacodynamics of sTNFr55-IgG (Ro 45̞2081-Lenercept [LEN]) (S.C.) IN PATIENTS WITH RHEUMATOID

ARTHRITIS (RA), Ovid, Retrieved at: https://insights.ovid.com/arthritis-rheumatism/arhe/1998/09/001/assessment-effect-anti-

drug-antibody-formation/158/00000889

chemicals into the bloodstream to fight an infection. Sepsis occurs when the body's response to these chemicals is out of balance,

conditions/sepsis/symptoms-causes/syc-

73 Information confirmed through conversations with Dr. Michael Weinblatt, rheumatologist at Brigham and Women's Hospital, Mike

Widmer, former Vice President and Director of Biological Sciences, and other former Immunex researchers.

74 Information confirmed through conversations with Dr. Michael Weinblatt, rheumatologist at Brigham and Women's Hospital, Mike

Widmer, former Vice President and Director of Biological Sciences, and other former Immunex researchers.

10 researchers Craig Smith, Ray Goodwin, and Patricia Beckmann were crucial in developing p75

TNF receptor technology for commercial use.75

Immunex worked with the lab of researcher Brian Seed at Massachusetts General Hospital to fusion technology for treatments intended to combat HIV. Seed leveraged insights he learned from making IgG fusion proteins for HIV to help in making Enbrel.76

Although Seed was the first to make the Ig fusion

technology, the patent for some of the technology was held by Genentech/Roche.77 Enbrel received FDA approval for treatment for rheumatoid arthritis on November 2,

1998.78 Once Enbrel was in clinical use, it attained

multibillion-per-year blockbuster sales. Immunex, and later Amgen, owed both Seed/Massachusetts General Hospital and Genentech/Roche considerable royalties The Amgen-Immunex Acquisition In early October, in a

Committee on Oversight and Reform hearing,

Congresswoman Porter questioned the current CEO of Amgen, Robert Bradway.81 Bradway downplayed the role of Immunex and Brian Seed in the development of Enbrel, prompting a former Immunex, and later Amgen, Principal Scientist to contact our office. Laurent Galibert, testimony and the transformation Galibert watched the company undergo after the acquisition. Through conversations with Galibert and multiple other former employees of Immunex/Amgen, our office pieced together a story of a small biotech company in which scientific discovery and innovation were devastated during an acquisition. Galibert characterized the acquisition, and many others like it, with a simple metaphor: you buy a hen house, burn the hen house, kill the chickens inside, and sell their eggs.

75 A Zigzagging Path Points Straight to Success, Science Mag, Retrieved at: https://www.sciencemag.org/careers/2011/03/zigzagging-

path-points-straight-success and Summary for Patent: RE36755, Retrieved at:

the development of several therapeutic fusion proteins that conceptually underlies much of the current biologics effort in the

Retrieved at: https://tmg.mgh.harvard.edu/about/who-we-are

applications which subsequently became the patents-in-suit and Immunex granted Roche the option to license its own patents and

International GMBH and Sandoz GMBH,

Retrieved at: https://www.bigmoleculewatch.com/wp-content/uploads/sites/2/2018/10/Sandoz-Corrected-Findings-of-Fact-

Conclusions-of-Law.pdf

78 Scientists who pioneered arthritis drug quit Amgen, Seattle Times, Retrieved at:

79 Lucrative Licensing Deals With Drug, Biotech Firms Are Raising Ethics Issues For Hospitals, Sherman, Silverstein, Kohl, Rose &

Podolsky, P.A., Retrieved at: https://www.sskrplaw.com/lucrative-licensing-deals-with-drug-biotech-firms-are-raising-et.html

80 Boston hospital rakes in $284M on drug rights, Fierce Healthcare, Retrieved at:

81 Rep. Katie Porter, Twitter, Retrieved at: https://twitter.com/RepKatiePorter/status/1311723496947494918

conversations with former Immunex, and later Amgen, employees, my staff found that they all painted a similar picture: after the acquisition, the innovative, creative culture the company had worked so diligently to foster 11 Galibert, a Principal Scientist at Immunex, stayed on with the company through the acquisition. He described the shift research, Amgen wanted to instead search for new products to acquire. Immunex had been a leader in immunotherapy, but much of the research they had in very early stages was quite risky, and, at the time, immunotherapy was a less full of amazing visionary scientists and the team they had was scientifically speaking could have eloped in terms of else thought it was a dream. It took everyone else 11 years to To avoid this risk, Amgen killed nearly all programs involving early immunotherapy research. Those few projects that were maintained were later successful, and Galibert believes it is likely others could have been fruitful had Amgen not mistakes. Abandoning immunotherapy when Immunex was holding a dominant position was one. What I find regrettable in this is not so much that a mistake was made but that it was sentiments. He had worked for Immunex for fourteen years as Senior Staff Scientist in the Molecular Biology Department before being promoted to a management position. He stayed with Amgen before leaving the company to work as a consultant. When he was a scientist at Immunex, his team collaborated with other companies and researchers, advancing cures faster and avoiding unnecessary pitfalls. Rather than working on research others had already found They used this information to prioritize their research, save money, and better direct efforts. When Immunex was acquired, many of their ongoing collaborations were quickly snuffed out, ending an effort that had helped to save lives and money. Site Head for Amgen Washington), shared with our office a cultural document that Immunex published in February 2002. The former Scientific Director at Amgen who worked for Immunex as well prior to the acquisition,82 explained to our staff: going into the acquisition, it, but unfortunately, they failed.

82 Individual requested that their name not be publicly disclosed in this report.

characterized the acquisition, and many others like it, with a simple metaphor: you buy a hen house, burn the hen house, kill the chickens inside, 12 Beth Fortmueller left Amgen two years after the acquisition. By the time she left, all of the Discovery Research leadership that had come with her had already left Amgen.83 She explained merger, but truly an acquisition.

Ŀėāł̪ŭat the time, Kevin Sharer84 held a meeting at Seattle Symphony Hall near the end

of the acquisition. The event was supposed to be an opportunity for Immunex employees to meet Sharer and get an understanding for his leadership and the future of the company. As employees continued to ask questions, he became visibly more frustrated. The atmosphere finally answered one question with a statement that definitively set the tone for the rest of This attitude was clear in further decisions that Amgen made about Immunex programs that they cut, in addition to those pipeline research projects that Amgen killed. Charles Maliszewski had helped lead a postdoctoral fellowship program at Immunex, training the fellows who produced interesting research and ideas for the company. Immunex leadership felt it was important to develop this talent not just for their company but for the world. It was among the most productive programs they had in terms of discovery, allowing unfettered, new ideas to develop in the company. Maliszewski described losing this program as That some of their greatest research came from these fellows was not surprising to Maliszewski, who explained that the reporting matrix at Immunex was not top down, but in fact very flat. Ideas from the most junior individuals, even those without an advanced degree, could percolate to the top level of the company, creating amazing benefits and fostering a great culture. Former employee Claudi Wyszynski explained further in the culture document,quotesdbs_dbs18.pdfusesText_24